Avenue Scotland are currently recruiting for a Project Regulatory Affairs Specialist
Main purpose of the job
To take a leading role in the regulatory compliance aspects of multi-disciplinary device development projects in the field of drug delivery products, in-vitro diagnostics, and surgical products. The position will require you to apply your regulatory compliance skills to the development of world-leading medical products for our clients around the globe.
Specific responsibilities
This position involves taking the lead role on regulatory compliance within development projects with exposure to all aspects of development from contract negotiation to final delivery. You will be involved in advising the project manager on the quality management system that needs to be in-place for any given project, and the implication this has for the execution of specific engineering design tasks. Significant project management tasks may also be a key part of the role.
You will use your strong regulatory expertise to develop relationships with current and future clients by understanding their needs and by assisting in writing proposals to define the work programmes. You will provide a regulatory point of contact within the company for clients. You will manage tasks within projects requiring delivery within tight timescales and budgets, managing both internal and external resources.
Your specific responsibilities will include:
Identification of product classification and approval authority
Definition of regulatory strategy for product or system developments
Definition of specific quality management processes, within our existing ISO 9001 system, to achieve regulatory compliance
Identification of compliance tasks in the overall development plan
Preparation of project quality, risk management, verification and validation plans
Identification and preparation of design verification protocols
Preparation of verification and validation reports
Identifying process validation requirements
Minimum requirements
To meet the requirements of this role you should have a high level of regulatory experience, preferably gained in a R&D environment. Exposure to the healthcare industry is vital, with experience at a pharmaceutical or medical device company being a strong advantage. This experience may have been gained in a regulatory role mainly concerned with the preparation of approval submissions (and experience in European and FDA submissions is preferred), or you may have performed a project QA role. Therefore your degree may be in life-sciences or engineering. In either case your key ability will be skill and experience to interpret downstream requirements into what this means for the development team right now.
Your specific expertise will include some of the following:
Regulatory/Quality planning
Risk analysis techniques (eg FTA and/or FMEA)
Software V&V planning
SOP preparation
V&V Protocol preparation
Design control
Change control
Standards analysis
Experience in clinical trials design and planning is desirable, as is the knowledge of the EMEA and FDA approvals process for combination products.
To apply, send your CV, Notice Period, Current Salary, Expected Salary
|
